Congratulations! So, you’ve decided to adopt a compliance software tool for your life science organization. However, you’re only at the start of a big implementation process—one that has a lot of moving parts and work attached. How do you make the start of using compliance software the best process it can be?
Whichever approach you choose to apply, a new software tool also depends on your business’s maturity in the marketplace, portfolios, size, project timelines, and so on. All of these factors influence your organization’s capabilities to adopt and use new tools, and should be evaluated early on in the process.
Getting buy-in on compliance software needs to happen at both management and development team levels. Higher-ups want to see how the tool improves efficiencies, reduces costs, and so on. Development team members—who will be using the tool daily—need to understand its value for their work and how it impacts their activities.
During the process of obtaining buy-in, it’s worthwhile to keep the discussion open, listen to concerns, and address questions people may have. As implementation kicks into gear, you can incorporate any feedback you get into that process. This can better align the tool to people’s expectations, unify goals for using the tool, and identify areas for future improvement.
Along with risk assessment, validation is another compliance activity that must be done when incorporating new software into your quality management system. Prior to full operation, your team should plan to run validation exercises to ensure integrity and performance. After that, establishing timelines, technical needs, and responsible parties for future validation allows you to manage this aspect of regulatory compliance.
While all these best practices and tips are aimed at making compliance software tool use easier to manage, the process is almost never smooth. Hitting bumps in the road should be expected; looking back at them allows your team to learn and adjust more easily. Conducting regular evaluations generates insight into:
From these, you can build on the things that are going well in adoption and come up with solutions for things that need improvement. Sharing these perceptions with the vendor is worthwhile, too; they may have thoughts or ideas that you may not have been able to see. They can then assist you in adjusting your version of the software to accommodate challenges and solutions that improve compliance activities in your organization.